Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

NCT07774897 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-08-19

No results posted yet for this study

Summary

Certain classical formulas in traditional Chinese medicine and dietary prebiotics have demonstrated beneficial effects on various aspects of suboptimal health status in previous studies. This research aims to evaluate the effects of Bao Yuan Tang full-component extract combined with galactooligosaccharides on improving health-related outcomes in female registered nurse with suboptimal health status, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities.

Conditions

  • Sleep Disturbance
  • Fatigue Syndrome, Chronic
  • Endocrine Disorder
  • Glucose Metabolism Disorder
  • Lipid Metabolism Disorders

Interventions

DIETARY_SUPPLEMENT

Combination product (Bao Yuan Tang full-component extract 2.0g and galactooligosaccharides 2.0g)

Participants will receive a combination product consisting of Bao Yuan Tang full-component extract (2.0g) and galactooligosaccharides (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.

DIETARY_SUPPLEMENT

Bao Yuan Tang full-component extract 2.0g plus a placebo consisting of maltodextrin 2.0g

Participants will receive Bao Yuan Tang full-component extract (2.0g) plus a placebo consisting of maltodextrin (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.

DIETARY_SUPPLEMENT

Galactooligosaccharides 2.0g

Participants will receive galactooligosaccharides (2.0g) combined with a maltodextrin placebo (2.0g). The intervention will be administered twice daily, one sachet each time, for 3 weeks.

OTHER

maltodextrin placebo 4.0g

Participants will receive maltodextrin placebo (4.0g), administered twice daily, one sachet each time, for 3 weeks.

Sponsors & Collaborators

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    lead OTHER

Principal Investigators

  • Wenbo Meng, M.D., Ph.D. · LanZhou University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774897 on ClinicalTrials.gov